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510(k) K931655

P.F.C. BIPOLAR HIP SYSTEM by Johnson & Johnson Orthopaedics, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1994
Date Received
April 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Johnson & Johnson Orthopaedics, Inc.

  • K931466 — PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI (December 6, 1994)
  • K935452 — P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT (October 6, 1994)
  • K940190 — ULTIMA UNIPOLAR MODULAR HEAD (September 29, 1994)
  • K933275 — P.F.C. CERAMIC HIP HEAD (September 28, 1994)
  • K932595 — ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR (September 20, 1994)
  • K933867 — UNIVERSAL INSET PATELLA (June 6, 1994)
  • K935262 — P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA (June 3, 1994)
  • K931189 — P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET (February 9, 1994)
  • K931054 — TRICK MODULAR KNEE TIBIAL TRAY-POROUS (January 25, 1994)
  • K924340 — P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT (January 25, 1994)

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  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)